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Traditional Chinese medicine dispensing granules（TCMDGs）is the new type of decoction pieces with the development of modernization of TCM， which has received mixed opinions since its practical application. In 2021， the national departments issued Announcement on Ending the Pilot Work of TCMDGs， marking the end of the 28-year pilot work of TCMDGs， and eligible TCM enterprises can produce TCMDGs after filing. However， this does not mean that the preparation process， quality standard and efficacy research of TCMDGs have been developed and matured， on the contrary， there are still some problems that need to be solved and gradually improved. For example， in the production process， there are problems such as unclear， unified and non-standardized preparation parameters. In terms of quality control， there are some problems such as lack of producing area regulation， variety selection and processing specification. In terms of consistency evaluation with traditional decoction， there are problems such as unclear relationship between the chemical constituents and pharmacological effects of the two. Therefore， in view of some prominent problems of TCMDGs at present， this paper takes the published literature as the main data source and combines the specific requirements of the code or technical standards such as the 2020 edition of Chinese Pharmacopoeia， Publicity of the Unified Standard on the Varieties of TCMDGs， Quality Control and Standard Formulation Technical Requirements of TCMDGs. The production process of TCMDGs， the origin and variety of raw materials， the processing of decoction pieces， the quality control standard and the consistency evaluation of formula granules and traditional decoction were sorted out and visualized by literature mining， data analysis and list comparison. Based on the analysis results， the following suggestions were made. In terms of preparation process， the completeness and standardization of process parameters should be strengthened. In terms of quality evaluation， attention should be paid to the relationship between the authenticity， variety， processing and quality of medicinal materials. In the consistency evaluation of formula granules and traditional decoction， the deep difference and mechanism between TCMDGs and traditional decoction were discussed by combining structural Chinese medicine， quality marker（Q-Marker） theory and physicochemical characterization， so as to provide reference for the application and development of TCMDGs.
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OBJECTIVE To compare the change law of multi-components in the extraction process between Liuwei dihuang powder decoction pieces and traditional decoction pieces （hereinafter referred to as powder decoction pieces and traditional decoction pieces）， and to provide scientific basis for the modern technology research of Liuwei dihuang formula. METHODS Taking powder decoction pieces and traditional decoction pieces as samples， the samples were taken when soaking for 60 min， at 0， 5， 10， 15， 20， 25， 30， 40， 50， 60 min of the first decocting and at 5， 10， 20， 30， 40 min of the second decocting， respectively. HPLC method was used to establish the fingerprints of 2 kinds of decoction pieces with different decocting time. The similarity evaluation and peak identification were performed. The contents of 8 components including 5-hydroxyfurfural， catechin， monoglycoside， loganin， swertin glycoside， dihydroquercetin， paeonol and benzoyl paeoniflorin were all determined. RESULTS With different decocting time， the similarties between 2 kinds of decoction pieces and their respective control fingerprints R were all greater than 0.98. In the fingerprints of traditional decoction pieces， five chromatographic peaks were identified， namely， 5- hydroxyfurfural， monetin， swertiaoside， dihydroquercetin and paeonol； in the fingerprints of powder decoction pieces， six chromatographic peaks were identified， namely， 5-hydroxyfurfural， monoglycoside， swertiamarin， dihydroquercetin， paeonol and benzoyl paeoniflorin. The results of content determination showed that in the first 5 minutes of the first decocting， the decocting rate of almost all the ingredients in the powder decoction pieces was faster than that of the traditional decoction pieces； after 40 min， the contents of other active ingredients were lower than those of traditional decoction pieces except for 5-hydroxyfurfural and paeonol. In the process of second decocting， except for paeonol and loganin， the contents of other ingredients in powder decoction pieces were higher than that in traditional decoction pieces； catechin was completely decocted from the traditional decoction pieces in the first decocting， while it could still be detected in the powder decoction pieces in the second decocting. There was little difference in the total decocted amount of the 8 ingredients in the two decoction pieces. CONCLUSIONS The chemical composition of powder decoction pieces of Liuwei dihuang formula has no obvious advantages compared with traditional decoction pieces， and can not save the decocting time and the amount of medicinal materials.
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OBJECTIVE：To investigate the effects of the integration of field processing and decoction piece processing （hereinafter called “Integration”for short ）on chemical composition of Ligusticum chuanxiong decoction pieces. METHODS ：Fresh L. chuanxiong were collected from Dujiangyan and Pengzhou of Sichuan ；integrated decoction pieces of L. chuanxiong were prepared after washing ，drying in the shade （to about 28％ moisture content ），slicing and drying ；traditional decoction pieces was prepared after drying in the shade ，adding water to moisten （to the core ），slicing and drying. HPLC fingerprints of two kinds of decoction pieces samples （with 10 batches in each type ）were established. The determination was performed on WondaSil C 18 column with mobile phase consisted of 1％ formic acid solution-acetonitrile （gradient elution ）at the flow rate of 1.0 mL/min. The column temperature was 30 ℃. The detection wavelength was set at 285 nm，and the sample size was 10 μL. Using ligusticolide A as reference ，HPLC fingerprints of 20 batches of samples were drawn. The similarity of the fingerprints was evaluated with Similarity Evaluation System for Chromatographic Fingerprint of TCM （2004A edition ），and then common peaks were confirmed. The contents of chlorogenic acid ，ferulic acid and ligusticolide A were determined by above chromatographic condition. Single factor variance analysis was performed for comparison of the contents. RESULTS ：The similarity of HPLC fingerprints among 20 batches of samples was above 0.900. A total of 16 common peaks were determined ，7 of which were chlorogenic acid ，ferulic acid，ligusticolide Ⅰ，pine cypress ferulinate ，ligusticolide A ，n-butylphthalide and ligustilide ，respectively. The linear range of chlorogenic acid ，ferulic acid and ligusticolide A were 0.008-0.200 mg/mL（r＝0.999 9），0.010-0.140 mg/mL（r＝0.999 2）and 0.100-0.600 mg/mL（r＝0.999 3）；the limits of quantification were 0.002 8，0.000 6 and 0.005 0 mg/mL，respectively；the limits of detection were 0.000 8，0.000 1 and 0.001 0 mg/mL，respectively；RSDs of precision ，reproducibility and stability tests were all lower than 3％，and average recoveries were 96.27％-102.02％（RSD＜2％，n＝6）. The contents of above compositions in the integrated decoction pieces and traditional decoction pieces were（1.677 0±0.311 0），（1.562 7±0.124 5），（9.494 0±1.351 3）mg/g and（1.300 2±0.469 2），（1.388 0±0.209 9），（9.811 7±1.098 9）mg/g，respectively；there was no statistical significance between 2 groups（P＞0.05）. CONCLUSIONS ：The chemical composition of each batch of samples of L. chuanxiong integrated decoction pieces and traditional decoction pieces is consistent ，and the content of index components as chlorogenic acid ，ferulic acid and ligusticolide A in the decoction pieces is not affected by the integration processing. This process is feasible to a certain extent.
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Objective: Taking Danggui Buxue Decoction (DBD) as the research object, the differences of chemical composition types and content among traditional decoction, self-made granule decoction and marketable granule decoction were compared, in order to provide scientific basis for clinical application of Chinese medicine formul granules. Methods: The fingerprint was established by HPLC. The value of the chemical composition, the content of the index components, the area of the common peak area, and the similarity of the fingerprint were evaluated, and the different dosage forms of the decoction of DBD were investigated. The effect of chemical composition on the chemical equivalence of traditional decoction and formula granules was compared. Results: The number of chromatographic peaks ranged from 15 peaks of traditional decoction to 13 (factory A), 12 (self-made), 11 (factory B), and 9 (factory C). The content of ferulic acid in formula granules was significantly different from that in traditional decoction (P formula granule decoction of factory A > self-made formula granule decoction > formula granule decoction of factory B > formula granule decoction of factory C. Content of campanulin was in order : self-made formula granule decoction > traditional decoction > formula granule decoction of factory A > formula granule decoction of factory B > formula granule decoction of factory C. The total peak area of formula granule decoction was lower than that of traditional decoction. If the traditional decoction was 1, the others (self-made and factories A, B, C) were equivalent to 0.95, 0.66, 0.40 and 0.47, respectively. Comparing with traditional decoction, self-made formula granule decoction and formula granules from factories A and B had higher similarity (0.97, 0.96, 0.98), while that from factory C was slightly lower (0.85). The main chromatographic peaks of DBD were found to be from the single herbs and no new chemical components were found. The disappearance of ingredients in formula granule Decoction was found. Conclusion: The content of index components and the number of chromatographic peaks of traditional decoction of DBD is higher than those in the formula granule decoction. There are some differences between them. This indicates that the clinical equivalence of formula granules is not consistent with the reality of decoction, so the recommended clinical equivalence of formula granules of traditional Chinese medicine should be corrected to promote rational clinical application, which can provide scientific research ideas for the unified management of the quality of formula granules of Chinese materia medica.
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Objective: To compare the content of total saponins and total polysaccharides between formula granule and traditional decoction of Sijunzi decoction.Methods: UV spectrophotometry was used to determine the content of total saponins and total polysaccharides in formula granule and traditional decoction of Sijunzi decoction respectively at the wavelength of 540 nm and 488 nm.Results: The absorbance of ginsenoside Re had a good linear correlation with the concentration within the range of 10.909-65.454 μg · ml-1 (r=0.999 7), and the average recovery was 98.49%(RSD=0.85%, n=6);the absorbance of D-anhydrous glucose had a good linear correlation with the concentration within the range of 2.160-12.960 μg · ml-1 (r=0.999 7), and the average recovery was 99.46%(RSD=0.73%, n=6).The contents of total saponins from 3 batches of formula granule were slightly higher than those from traditional decoction,and that of total polysaccharides in formula granule was slightly lower than that in traditional decoction,and there was no significant difference between the two groups (P>0.05)Conclusion: The difference of material basis between formula granule and traditional decoction of Sijunzi decoction is small, and formula granule is more feasible for clinical application.
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OBJECTIVE:To establish the HPLC fingerprints for Sini decoction and compare the differences of compositions of Sini decoction prepared by traditional decoction and modern machine decoction. METHODS:HPLC was performed on the column of Kromasil C18 with mobile phase of acetonitrile-0.1% phosphoric acid(gradient elution)at a flow rate of 1.0 ml/min,the detec-tion wavelength was 235 nm,column temperature was 30 ℃,and injection volume was 10 μl. The HPLC fingerprints of 10 batch-es of Sini decoction were determined with reference peak of liquiritin peaks,and common peak identification and similarity evalua-tion were conducted by using Chromatographic Fingerprint Similarity Evaluation System(2004 A edition). RESULTS:There were 18 common peaks and the similarity was no less than 0.982. According to the verification,the fingerprint of 10 batches of Sini de-coction showed good similarity with reference fingerprint,and the similarity of 10 batches of Sini decoction was high,which was prepared by the 2 methods. CONCLUSIONS:The established fingerprint is specific and stable,and can provide reference for quali-ty evaluation and control for Sini decoction;and there are no obvious differences in the main chemical compositions of Sini decoc-tion prepared by traditional decoction and modern machine decoction.
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Objective:To establish a method for the determination of specnuezhenide in traditional decoction and granules of Zish-enwufa formula, and compare the content between them. Methods:HPLC was used for the determination. The samples were analyzed on a Waters Symmetry C18 column (150 mm × 3. 9 mm,5 μm) with acetonitrile-water (16 ∶84) as the mobile phase. The flow rate was 1. 0 ml·min-1 and the detection wavelength was 224nm. Results: A good linearity of specnuezhenide was within the range of 0.179 2-3.316 μg(r=0.999 9),and the average recovery of berberine hydrochloride was 101.65% with RSD of 1.49%(n=6). Conclusion:The determination method is simple, accurate and sensitive with good reproducibility,which can be used for the determi-nation of specnuezhenide in the preparation. The content of specnuezhenide in the traditional decoction and granules of Zishenwufa for-mula is similar.
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Objective: To compare the content of chemical components in each drug in formula granule and traditional decoction of Rehmanniae Decoction with six ingredients. Methods: By using high performance liquid chromatography analysis and various chromatographic conditions, the contents were determined respectively, which were listed as follows: acteoside, loganin, paeonol, allantoin, pachymic acid and alisol B 23-acetate. Results: The contents of acteoside, loganin, paeonol, allantoin, pachymic acid and alisol B 23-acetate in traditional decoction were 304.5, 2 473.6, 3 135.1, 708.8, 5.9, and 104.4 μg/g, and they were 289.6, 3 685.7, 706.5, 714.2, 17.4, and 217.8 μg/g correspondingly in formula granule. The contents of acteoside and allantoin were basically the same between them; The contents of loganin, pachymic acid, and alisol B 23-acetate in formula granule were significantly higher than those in the traditional decoction; The content of paeonol in formula granule was significantly lower than that in the traditional decoction. Conclusion: The content difference of the chemical components is related to its chemical character between formula granule and traditional decoction.
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Objective: Patients and doctors often have questions about the equivalence of traditional and machinery decoctions. In this article, using Da-cheng-qi Decoction (DCQD) as a model of formula, traditional decoction (TD), machinery decoction under high pressure (MDHP), and machinery decoction under normal pressure (MDNP) were compared. Methods: For chemical components, HPLC fingerprints were established and evaluated using AHP combined with CRITIC weighing method; For animals' effects, the experiments of small intestinal propulsion were conducted; For clinical effects, a randomized clinical trial (RCT) was designed and performed. Results: Although there were some differences between TD and MDNP in chemical ingredients, there was no significant difference in animal experiments and clinical trials (P > 0.05). Conclusion: The traditional and machinery decoctions of DCQD could be used bioequivalently.
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Objective: To study the content difference of berberine hydrochloride, palmatine hydrochloride, jatrorrhizine hydrochloride, and paeoniflorin in Wujiwan traditional decoction, granule prescription, and compound granule using HPCE internal standard method. Methods: Capillary zone electrophoresis (CZE) method was used for a complete separation of the components, which was achieved with 50 mmol/L borax buffer-methanol (2:1), constant voltage of 25 kV, pressure injection 5 kPa × 15 s, electrolyle sealing 5 kPa × 10 s, and column temperature of 15°C. Results: The capillary electrophoresis method is simple and accurate. The contents of the three alkaloids in the granule prescription were obviously higher than those in traditional decoction and compound granule. Conclusion: This method is instructive for clinical application and quality control of Wujiwan prescription and compound granule.
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OBJECTIVE: To study and compare the compositions of traditional decoction and compatible granules of Duhuo Jisheng Tang and reveal their differences in inner quality. METHODS: The compositions of eight medicines, i.e., duhuo, sangjisheng, danggui, chuangxiong, fuling, baishao, qinjiao and gancao in traditional decoction and dispensing granule decoction, were identified by TLC. And the contents of paeoniflorin were determined by HPLC. RESULTS: There were more spots of the eight than dispensing granules. The content of peaoniflorin of the traditional decoction was 29.37mg·g-1. The content of peaoniflorin of the dispensing granule decoction is 2.59 mg·g-1. CONCLUSION: Composition contents in traditional decoction from Duhuo Jisheng Tang is higher than that of dispensing granule decoction.
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OBJECTIVE:To discuss the importance and prospects of the reforming of the Chinese medicinal decoction pieces. METHODS: The advantages and disadvantages of all kinds of decoction pieces(categorized by particle diameter) in preparation, application and management were analyzed comprehensively. RESULTS & CONCLUSION: Comminuting and extracting are two basic approaches for the current reform of the Chinese medicinal decoction pieces, and the reform of the decoction pieces is mainly aimed at nano-Chinese medicinal decoction pieces.
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0.05). In the fever experiment,the two kinds of HJD in different doses showed antipyretic effect to various degrees,but the dispensing granule decoction of HJD had the better effect,and the effect in the middle-and high-dose groups was superior to that of the low-dose groups (P
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OBJECTIVE:To study the effects of modern decoction method vs. traditional decoction method on decoction rate and decoction quality. METHODS: The advantages and disadvantages were compared between the two decoction methods through analysis on the whole decoction process and the storage of the decoction before oral administration taking major components or active components as parameters. RESULTS: As compare with traditional decoction method, the modern decoction method had more advantages for in which the operation is standard, the contents of active components were high, and the quality control can be performed from many ways. CONCLUSION: The modern decoction method deserves to be popularized.